Levofloxacin Alter 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacin Alter 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Levofloxacin Alter is and what it is used for
2. What you need to know before taking Levofloxacin Alter
3. How to take Levofloxacin Alter
4. Possible side effects
5. How to store Levofloxacin Alter
6. Contents of the pack and other information

1. What Levofloxacino Alter is and what it is used for

The name of this medicine is Levofloxacino Alter 500 mg film-coated tablets. Levofloxacino Alter contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone-type antibiotic and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the sink or in household waste.

Levofloxacino Alter can be used to treat infections in:

• the sinuses
• the lungs, in people with long-term respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Alter may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacin Alter

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue
• You have or have had epilepsy
• You have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type medications. Tendons are the tissues that connect your muscles to your skeleton
• You are a child or adolescent undergoing growth
• You are pregnant, could become pregnant, or think you might be pregnant
• You are breastfeeding

Do not take this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacin Alter.

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Alter, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking this medicine if:

• You have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking levofloxacin.
• You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacin Alter with other medicines”)
• You have ever had a seizure (epileptic fit)
• You have suffered brain damage due to stroke or other brain injury
• You have kidney problems
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine
• You have ever had mental health problems
• You have ever had heart problems: caution is required when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Taking Levofloxacin Alter with other medicines”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• Immediately consult an ophthalmologist if you experience any changes in vision or any eye problems.
• You have been diagnosed with an enlargement or “lump” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have previously experienced aortic dissection (tearing of the aortic wall).
• If you have been diagnosed with heart valve insufficiency (heart valve regurgitation).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

Inform your doctor or pharmacist before taking Levofloxacin Alter if you are unsure whether any of the above conditions apply to you.

During treatment with this medicine

• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to stop levofloxacin treatment and initiate appropriate therapy.
• If you have nausea, general discomfort, severe discomfort or persistent or worsening stomach pain, or vomiting—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
• If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Levofloxacin Alter. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Alter, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Levofloxacin Alter and inform your doctor immediately to prevent potentially irreversible nerve damage.

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular patches, often with blisters in the center. Sores may also appear in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen in blood tests, elevated levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.

Serious, disabling, long-lasting, and potentially irreversible adverse effects: Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Alter, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking Levofloxacin Alter, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Taking Levofloxacin Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because Levofloxacin Alter may affect how other medicines work. In addition, some medicines may affect how Levofloxacin Alter works.

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with Levofloxacin Alter:

• Corticosteroids, sometimes called steroids—used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin—used to thin the blood. You may have a higher risk of bleeding. Your doctor may need periodic blood tests to check your blood clotting
• Theophylline—used for breathing problems. You may have an increased risk of seizures when taken with Levofloxacin Alter
• Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. You may have an increased risk of seizures when taken with Levofloxacin Alter
• Cyclosporine—used after organ transplants. You may be more likely to experience cyclosporine side effects
• Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (“macrolide” antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special caution is required when taking these medicines with Levofloxacin Alter. If you have kidney problems, your doctor may consider giving you a lower dose.

Do not take Levofloxacin Alter tablets at the same time as the following medicines, as they may affect how Levofloxacin Alter works:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminium or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosine or sucralfate” below.

Opiate urine testing

Urine tests may show "false positive" results for strong painkillers called "opiates" in patients taking Levofloxacin Alter. Inform your doctor that you are taking Levofloxacin Alter if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a "false negative" result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, could become pregnant, or think you might be pregnant
• You are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

3. How to take Levofloxacino Alter

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth
• Swallow the tablets whole with some water
• The tablets may be taken during or between meals

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when it is cloudy) while you are taking this medicine and for two days after stopping it, as your skin will become much more sensitive to sunlight and may burn, sting, or even blister if you do not take the following precautions:

• Be sure to use sunscreen creams with a high protection factor
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet (UVA) lamps

If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as Levofloxacino Alter. You must take these medicines at least two hours before or two hours after taking Levofloxacino Alter.

What dose should you take?

• Your doctor will decide how much Levofloxacino Alter you should take.
• The dose will depend on the type of infection you have and where in your body the infection is located.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—ask your doctor.

Adults and elderly patients

Sinus infection

• one tablet of Levofloxacino Alter 500 mg once daily

Lung infection in people with long-term respiratory problems

• one tablet of Levofloxacino Alter 500 mg once daily

Pneumonia

• one tablet of Levofloxacino Alter 500 mg once or twice daily

Urinary tract infection, including kidneys or bladder

• half or one tablet of Levofloxacino Alter 500 mg daily

Prostate infection

• one tablet of Levofloxacino Alter 500 mg once daily

Skin and soft tissue infection, including muscles

• one tablet of Levofloxacino Alter 500 mg once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacino Alter than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeats, as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Alter

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Levofloxacino Alter

Do not stop your treatment with Levofloxacino Alter even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these are mild to moderate effects and tend to disappear in a short time.

Stop treatment with Levofloxacino Alter and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

Very rare (may affect up to 1 in 10,000 people)

• If you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop treatment with Levofloxacino Alter and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

Rare (may affect up to 1 in 1,000 people)

• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH)
• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)

Very rare (may affect up to 1 in 10,000 people)

• Burning, tingling, pain, or numbness. These may be signs of what is known as “neuropathy”

Frequency not known (cannot be estimated from available data):

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of skin and eyes, dark urine, burning sensation or painful abdomen upon palpation. These may be signs of liver problems, which may include fulminant liver failure

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking Levofloxacino Alter.

Inform your doctor if any of the following adverse effects worsen or last longer than a few days:

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting, and diarrhoea
• Increase in levels of certain liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection caused by Candida, which may require treatment
• Changes in white blood cell count in blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalized weakness

Rare (may affect up to 1 in 1,000 people)

• Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia)
• Decreased number of white blood cells in blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Tingling sensation in hands and feet (paraesthesia)
• Disorders of the ear (tinnitus) or vision (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)
• Changes in kidney function and, occasionally, kidney failure that may result from an allergic-type reaction in the kidney called interstitial nephritis
• Fever
• Clearly demarcated erythematous patches with or without blisters that develop within hours of levofloxacin administration and heal with post-inflammatory hyperpigmentation; typically, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Frequency not known (cannot be estimated from available data):

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic-type shock)
• Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important in people with diabetes
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Hearing problems or hearing loss
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction of muscle (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonia)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Alter

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Levofloxacino Alter

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components (excipients) are:

• Core: crospovidone, hypromellose, microcrystalline cellulose and sodium stearyl fumarate.
• Coating: hypromellose, titanium dioxide (E 171), talc, macrogol, yellow iron oxide (E 172) and red iron oxide (E 172).

Appearance of the product and contents of the container

Levofloxacino Alter are film-coated tablets for oral use. The tablets are oblong, scored and pink in colour.

They are available in packs of 7 and 14 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about anything, consult your doctor or pharmacist.

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/